Fastener apparatus for tissue and methods of deployment and manufacture

ABSTRACT

An apparatus and method for connecting two tubular vessels together in a side-by-side or tangential manner is disclosed. The apparatus has an annulus and at least one series of fingers connected to and extending away from the annulus. Each finger is preferably heat-formed into an arcuate shape. In use, a deployment apparatus is used to constrain the fingers of the apparatus to be in a relatively planar configuration. The deployment apparatus containing the apparatus is placed between and in contact with the two tubular vessels so that one tubular vessel is above the device and one tubular vessel is below the device and so that the fingers of the device come into contact with the tissue of the vessels. As the fingers penetrate the vessels the constraint on the fingers is removed so that the fingers can assume their unbiased, heat-formed arcuate shape. In this way, the fingers penetrate and grasp the tissue of the vessels so that the apparatus grasps the vessels and pulls the vessels toward each other.

CROSS REFERENCE TO RELATED APPLICATION

This divisional application claims priority to U.S. application Ser. No.11/237,132, filed Sep. 27, 2005, which claims the benefit of U.S.Provisional Application Ser. No. 60/613,434, filed Sep. 27, 2004, whichare all incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to methods and devices for surgicallyjoining separate pieces of tissue to one another, and more particularlyto surgically joining a tubular graft of tissue to a separate piece oftissue.

2. Related Art

In performing bypass surgery, it is a known practice to repair a cloggedor an otherwise damaged segment of tubular tissue, for example acoronary artery, by attaching a healthy section of artery, for example,a mammary artery, to the tubular tissue below the clog or damagedsegment so that blood flows from the healthy section of artery into thetubular tissue below the clogged or damaged segment. In addition, it isalso known to bypass a clogged or damaged section of artery (e.g., acoronary artery) by forming a graft made of a section of vein harvestedfrom elsewhere (e.g., a Saphenous vein harvested from the thigh)extending from the aorta to a section of the clogged or damaged arterybeyond the clog or damage. The resulting graft is known as a CoronaryArtery Bypass Graft (CABG—pronounced “cabbage”) and the procedure toform the graft is known as a CABG procedure.

While performing the procedures mentioned above, a surgeon ordinarilywill perform a sternectomy, a procedure to open the patient's chest toprovide access to the patient's heart. Thereafter, the patient istypically put on a bypass system that performs the function of thepatient's own heart and lungs as well as cools and warms the patient'sblood. As the patient is put on the bypass system, the patient's heartis stopped or “arrested” so that the surgeon may perform the CABGprocedure.

It is important that each end of the CABG graft is well attached to theaorta or coronary artery, respectively. This is necessary in order toprovide a leak-proof anastomosis and also to allow the tissue to healtogether into a strong, leak-proof connection. This connection isgenerally done by the surgeon making numerous stitches of suture(typically 6-8 on each end of the graft) between the vessel and thetissue that the graft is being joined to. In some cases, the surgeonmust replace sutures that do not create a leak-proof anastomosis betweenthe pieces of tissue. After the CABG procedure is complete, the patientis taken off the bypass system, the patient's heart allowed to restartand the patient's chest closed.

The entire procedure is ordinarily quite exhausting and requires a longtime to complete the procedure, generally ranging between 2 to 6 hoursor more. Statistically, 3-7% of patients that are put on a bypass systemexperience some form of neurological complications. The longer thepatient is on the bypass system, the more likely he or she is toexperience such complications. It typically takes a surgeon between 6-12minutes to attach each end of the graft to the aorta and coronaryartery, respectively. Much of the surgeon's time is spent making certainthat the segments of tissue are joined together in a leak-proofanastomosis. Generally, this requires the surgeon to make numerousstitches of suture between the segments of tissue being joined to oneanother, and in some cases replacing sutures that do not create aleak-proof anastomosis between the pieces of tissue.

Though using sutures to join segments of tissue to one another in openheart surgery, or other forms of surgery, has proven successful, notonly does it require a longer than desirable amount of time in surgery,there is also a danger of the suture becoming damaged. Damage to aportion of the suture may occur in many ways, such as throughinadvertent grasping or clamping by a surgical instrument or throughnicking a suture with the needle as an adjacent suture is installed.Ordinarily, a damaged piece of suture has a substantially reducedtensile strength and thus may ultimately fail to maintain the pieces oftissue joined to one another.

SUMMARY OF THE INVENTION

In accordance with one aspect of the invention, a device for connectingtwo tubular vessels together in a side-by-side or tangential manner isdisclosed. The device has an annulus and at least one series of fingersconnected to and extending away from the annulus. In the preferredembodiment there are two sets of fingers connected to and extending awayfrom the annulus in opposite directions. Each finger is preferablybiased into an arcuate shape.

In use, a deployment apparatus is used to constrain the fingers of thedevice to be in a relatively planar configuration. The deploymentapparatus containing the device is placed between and in contact withthe two tubular vessels so that one tubular vessel is above the deviceand one tubular vessel is below the device and so that the fingers ofthe device come into contact with the tissue of the vessels. As thefingers penetrate the vessels the constraint on the fingers is removedso that the fingers can assume their unbiased arcuate, heat-shapedconfiguration. In this way, the fingers penetrate and grasp the tissueof the vessels so that the device grasps the vessels and pulls thevessels toward each other. After the device is deployed in the tissue ofthe vessels so that the fingers enter into and grasp the tissue, acutting surface cuts the tissue between the fingers thereby forming anopening from one vessel through the device to the other vessel.

An object, feature or advantage of this invention, in one or moreembodiments of the invention, is to provide an apparatus and method ofdeployment that provides a secure and reliable side anastomosis betweena tubular duct and a wall of a vessel.

Another object, feature or advantage of this invention, in one or moreembodiments of the invention, is to provide an apparatus and method ofdeployment that establishes a quick biocompatible bond between matingtissues.

Another object, feature or advantage of this invention, in one or moreembodiments of the invention, is to provide an apparatus and method ofdeployment that imparts a biasing force to maintain connected tissues inabutting contact with one another.

Another object, feature or advantage of this invention, in one or moreembodiments of the invention, is to provide an apparatus and method ofdeployment that readily penetrates tissue without damaging the tissue.

Another object, feature or advantage of this invention, in one or moreembodiments of the invention, is to provide an apparatus and method ofdeployment that provides a quick and reliable mechanism in which toattach separate tissues to one another.

Another object, feature or advantage of this invention, in one or moreembodiments of the invention, is to provide an apparatus and method ofdeployment that is of relatively simple design and is economical inmanufacture and assembly and is efficient in use.

In accordance with another aspect of the invention, an apparatus forsecuring a tubular duct having a wall to a vessel having a wall in aside by side configuration includes a circumferentially continuousannulus having a first set of fingers extending from the annulus in afirst direction. The first set of fingers are configured for automaticmovement from a first biased configuration toward an unbiased,heat-formed, relaxed second configuration. The first set of fingers isconfigured to penetrate and grasp the wall of either the tubular duct orvessel as they move from the first configuration toward the secondconfiguration.

In accordance with yet another aspect of the invention, the apparatuscan include a second set of fingers extending at least in part from theannulus in a second direction generally opposite the first direction ofthe first set of fingers. The second set of fingers is configured forautomatic movement from a first biased configuration toward an unbiased,heat-formed, second relaxed configuration. The second set of fingers isconfigured to penetrate and grasp the other of the wall of either thetubular duct or vessel as they move from the first configuration towardthe second configuration, where the first and second sets of fingerspenetrate opposite ones of the wall of the tubular duct and the vessel.

In accordance with yet another aspect of the invention, a method fordeploying a fastener to secure a tubular duct having a wall to a vesselhaving a wall in a side-by-side configuration is provided. The methodincludes constraining a first set of fingers of the fastener with adeployment apparatus to move the first set of fingers into a biasedstate; disposing the constrained fastener between the tubular duct andvessel; and releasing the constrained fastener from the deployment toolto allow the first set of fingers to assume a relaxed, unbiased shapeand penetrate and grasp at least one of the tubular duct and vessel sothat the fastener grasps and fixes the tubular duct and vessel to eachother.

In accordance with yet another aspect of the invention, the method canfurther include forming an opening within at least one of the tubularduct and vessel to allow blood to flow through the opening by extendinga cutting member on the deployment tool between the first set of fingersand cutting tissue of at least one of the tubular duct and vessel withthe cutting member.

In accordance with yet another aspect of the invention, the method canfurther include constraining a second set of fingers of the fastenerwith the deployment apparatus to move the second set of fingers into abiased state and allowing the second set of fingers to assume a relaxed,unbiased shape and penetrate and grasp at least one of the tubular ductand vessel upon releasing the constrained fastener from the deploymenttool.

In accordance with yet another aspect of the invention, the method canfurther include biasing the first and second sets of fingers into asubstantially coplanar relation with one another while constraining thefirst and second sets of fingers with the deployment tool.

In accordance with yet another aspect of the invention, the method canfurther include allowing the first and second sets of fingers to take onan arcuate heat-shaped, relaxed configuration upon releasing theconstrained fastener from the deployment tool.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, features and advantages of this invention willbecome apparent from the following detailed description of the preferredembodiments and best mode, appended claims and accompanying drawings inwhich:

FIG. 1 is a broken away perspective view showing a fastener apparatusconstructed according to one presently preferred embodiment of theinvention attaching the tubular graft to the heart wall providing ablood flow path between the tubular graft and the artery underlying theheart wall;

FIG. 2 is a perspective view of the fastener apparatus of FIG. 1 in apreformed state of construction;

FIG. 3 is a perspective view of the fastener apparatus of FIG. 1 infirst and a second configuration.

FIG. 4 is a cross-sectional view of the apparatus maintained between apair of plates with a sharpening tool forming bevels on a first set offingers of the apparatus;

FIG. 5 is a cross-sectional view of the apparatus maintained betweenanother pair of plates with a sharpening tool forming bevels on a secondset of fingers of the apparatus;

FIG. 6 is a plan view of an annulus of a fastener apparatus constructedaccording to another embodiment of the invention shown in a preformedstate of construction;

FIG. 7 is a plan view of the annulus of FIG. 6 in a heat set form andshown in an unbiased state;

FIG. 8 is a plan view of the annulus of FIG. 6 in a closed orunder-tension state;

FIG. 9 is an exploded perspective view of the annulus of FIG. 7 with aplurality of fingers arranged to be received in a corresponding numberof openings in the annulus;

FIGS. 10A-10G are schematic side views of a deployment apparatus shownjoining a tubular duct to a vessel;

FIG. 11 is a perspective view of a deployment apparatus with a tubularduct received thereon overlying another tubular duct within a vessel;

FIG. 12 is a perspective view of the deployment apparatus of FIG. 11showing the fastener apparatus loaded therein and a receptacle of thedeployment apparatus with a cutter shown in retracted and extendedpositions;

FIG. 13 is a view similar to FIG. 12 with the cutter removed and showingthe fastener apparatus in an initially loaded position and a deployedposition;

FIG. 14 is an enlarged perspective view of a portion of a heart showinga point of attachment of a tagging suture to a tubular duct within theheart;

FIG. 15 is a view similar to FIG. 14 showing the tagging suture receivedthrough the deployment apparatus and attached to a tubular duct graft;

FIG. 16 is a view similar to FIG. 15 showing the graft of FIG. 15received on the receptacle of the deployment apparatus;

FIG. 17 is a view similar to FIG. 16 showing the deployment apparatusdisposed in position to initiate attachment of the graft to the tubularduct underlying the heart wall;

FIG. 18 is a view similar to FIG. 17 showing the fastener apparatusbeing deployed to form an anastomosis between the graft and the tubularduct underlying the heart wall;

FIG. 19 is a view similar to FIG. 18 showing the cutter being moved fromits extended position toward its retracted position to form and openingbetween the graft and the tubular duct within the heart;

FIG. 20 is a perspective view of the graft shown attached to the heartwall with an end of the graft sutured closed;

FIG. 21 is an enlarged partial cross-sectional view of the deploymentapparatus overlying in a heart wall in abutting contact therewith withthe fastener apparatus shown in its non-deployed configuration;

FIG. 22 is a view similar to FIG. 21 with the fastener apparatus shownin a partially deployed configuration;

FIG. 23 is a view similar to FIG. 22 with the fastener apparatus shownin a more advanced state of deployment;

FIG. 24 is a view similar to FIG. 23 with fastener apparatus shown in amore advanced state of deployment;

FIG. 25 is a view similar to FIG. 24 with fastener apparatus shown in amore advanced state of deployment;

FIG. 26 is a view similar to FIG. 25 with the cutting mechanism shown inan initial cutting position;

FIG. 27 is a view similar to FIG. 26 with the cutting mechanism shown ina final cutting position;

FIG. 28 is an enlarged cross-sectional view showing the fastenerapparatus fully deployed to form an anastomosis between a side wall ofthe tubular duct and the heart wall to provide blood flow between thetubular graft and an artery underlying the heart wall;

FIG. 29 is a broken away perspective view showing a fastener apparatusconstructed according to another presently preferred embodiment of theinvention attaching a tubular duct to a heart wall providing a bloodflow path between the tubular duct and an artery underlying the heartwall;

FIG. 30 is a perspective view of the fastener apparatus of FIG. 29 in apreformed state of construction;

FIG. 31 is a perspective schematic view of the fastener apparatus ofFIG. 29 shown in a biased state and being received within a receptacleof an alternate embodiment of a deployment apparatus for disposal withinthe tubular duct;

FIG. 32 is an enlarged cross sectional view of the fastener apparatusreceived within the deployment apparatus of FIG. 31;

FIG. 33 is a schematic view of another embodiment of an annulus for afastener apparatus according to another embodiment of the invention;

FIG. 34 is a schematic view of another embodiment of an annulus for afastener apparatus according to another embodiment of the invention;

FIG. 35 is a bottom view of a fastener apparatus constructed accordingto another embodiment of the invention;

FIG. 36 is a partial top view of the fastener apparatus of FIG. 35; and

FIG. 37 is a schematic perspective view of yet another embodiment of afastener apparatus constructed according to another embodiment of theinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, an apparatus, referred to hereafter as a fastener10, is shown making a generally tangential anastomosis between twopieces of tissue, represented here as a wall 11 of a generally tubularduct 12, for example and without limitation, a graft of an artery orvein, and a wall 14 of a vessel 16, for example and without limitation,a wall forming a coronary artery. The anastomosis established by thefastener 10 provides a sutureless connection between a wall 11 of thetubular duct 12 and the wall 14 of a vessel 16, thereby facilitatingmaking a tangential connection between the duct 12 and the vessel 16.Desirably, the fastener 10 biases the tubular duct 12 and the wall 14 ofthe vessel 16 toward one another, thereby establishing a leakproofattachment between the tubular duct 12 and the vessel 16. Additionally,the continual bias imparted by the fastener 10 between the tubular duct12 and the wall 14 of the vessel 16 facilitates the formation of abiological bond between the tubular duct 12 and the vessel 16 as thepatent heals after the CABG procedure.

Referring to FIGS. 1-3, the fastener 10 has an annulus 18 with aperpendicular axis 20 and a longitudinal axis 22. The annulus 18 has aflange 19 with a first set of fingers 24 and a second set of fingers 26.Fingers 24, 26 extend away from the annulus 18. In the preformed stateof construction shown in FIG. 2, the fingers 24, 26 extend radiallyinward from the annulus 18. However, as shown in the 1.sup.stconfiguration of FIG. 3, fingers 24, 26 are biased to extend away fromannulus 18 generally in opposite directions from the annulus 18 and in arelatively planar fashion, prior to the fingers 24, 26 taking on agenerally arcuate, curved, or hook shaped configuration. Further, asshown in the 2.sup.nd configuration of FIG. 3, the first set of fingers24 are biased to extend generally axially from the annulus 18 in onedirection to a 180 degree bend extending generally radially outwardlyfrom the perpendicular axis 20, thereafter, leading to free ends 28. Inaddition, as shown in the 2.sup.nd configuration of FIG. 3, the secondset of fingers 26 are biased to extend generally axially from theannulus 18 in another direction generally opposite the direction of thefirst set of fingers 24 to a 180 degree bend extending generallyradially outwardly from the perpendicular axis 20, thereafter, leadingto free ends 30.

In a relaxed condition shown in the 2.sup.nd configuration of FIG. 3,the annulus 18 generally remains generally oval in form, while also in arelaxed condition, the bends in the respective sets of fingers 24, 26,define the generally arcuate, or curved portions of the fastener 10 thatdefine a generally C-shaped fastener in axial cross-section. It shouldbe recognized that the fingers 24, 26, and annulus 18 may be formedhaving different geometries than described above, for example, insteadof the fingers 24, 26 having a continuous arcuate shape in their relaxedconfiguration, fingers 24, 26 may have a plurality of stepped linearsections defining the generally hook shaped configuration.

The first set of fingers 24 are moveable or bendable between a first,extended or biased, generally linear or at least partially flattenedconfiguration (FIG. 21) and a second, retracted or unbiased, at leastpartially arcuate, hook shaped, curled or otherwise nonlinearconfiguration (FIGS. 1 and 28) extending at least in part generallyradially outwardly from the perpendicular axis 20 to penetrate thetissue, in use. The second set of fingers 26 are moveable or bendablebetween a first, extended or biased, generally linear or at leastpartially flattened configuration and a second, retracted or unbiased,at least partially arcuate, hook shaped, curled or otherwise nonlinearconfiguration (FIGS. 1 and 28) extending at least in part generallyradially outwardly from the perpendicular axis 20 to penetrate thetissue, in use.

The first set of fingers 24 have an inner surface 32 and an outersurface 34 (FIG. 28) terminating at the free ends 28 that preferablydefine a point to facilitating piercing the tubular duct 12 and vessel16, for example. As best shown in FIG. 21, when the first set of fingers24 are in their biased and generally flattened configuration (as will beexplained hereafter), the inner surfaces 32 face generally away from oneanother along the perpendicular axis 20 and the outer surfaces 34 facegenerally toward one another along the perpendicular axis 20. Desirably,the first set of fingers 24 each have a bevel 36, such that when intheir biased configuration, the bevels 36 extend from each free end 32generally toward the inner surfaces 32 and the perpendicular axis 20.The bevels 36 help to form a sharpened end 32 to allow the end 32 tomore easily penetrate the tissue of a vessel.

The second set of fingers 26 have an inner surface 38 and an outersurface 40 terminating at the free ends 30 that preferably define apoint to facilitating piercing the tubular duct 12 and vessel 16, forexample. When the second set of fingers 26 are in their biasedconfiguration as shown in FIG. 21, he inner surfaces 38 face generallyaway from each other along the perpendicular axis 20 and the outersurfaces 40 face generally toward each other along the perpendicularaxis 20 and the inner surfaces 38 face generally away from theperpendicular axis 20. Desirably, the second set of fingers 26 each havea bevel 42 extending from each free end 30 generally toward the innersurfaces 38 and the perpendicular axis 20. The bevels 42 help to form asharpened end 30 to allow the end 30 to more easily penetrate the tissueof a vessel.

The first and second sets of fingers 24, 26 are generally constructed ina symmetrical relation to each other such that they are axially alignedwith one another about the circumference of the annulus 18, though theycould be staggered relative to one another, if desired in the intendedapplication. The fingers 24, 26 are constructed of a resiliently springymaterial having a shape memory so that they automatically return towardtheir unbiased, generally arcuate or hook shaped configuration when theforce displacing or extending the fingers 24, 26 to their biasedposition (as for example as shown in FIG. 21) is removed. Desirably,shape memory alloys are used in constructing the fastener 10, therebygiving the first and second sets of fingers 24, 26 their resilientlyspringy properties. Some exemplary materials include, withoutlimitation, nitinol, MP35N, tantalum, tungsten, platinum, 304 stainlesssteel, and other stainless steels, as desired for the intendedapplication. While those materials listed are generally consider thepreferred materials for the fingers 24, 26, any material that has ashape memory and that is biocompatible may be used including, withoutlimitation, plastics and ceramics.

The fastener 10 is desirably fabricated from a thin, flat sheet ofmaterial, for example, from one of the materials listed above or havingthe functional characteristics mentioned above. The thickness of thematerial used to construct the fastener 10 depends greatly on thephysical properties of the material including the elasticity of thematerial. As shown in FIG. 2, in fastener 10's initial construction, thefirst and second sets of finger 24, 26 extend radially inwardly from anannulus 18. Thereafter, fingers 24, 26 are heat formed into their finalshape (i.e., the shape having the bias to form the arcuate “C” shapeconfiguration described above), as is discussed hereafter in moredetail.

Desirably, when the fingers 24, 26 are in their biased, first positions,the material chosen remains in an elastic state of deformation, therebybiasing the fingers 24, 26 to return to their second, relaxed positions.Using 304 stainless steel, one of the materials listed above, athickness of about 0.0001″-0.0150″ is generally preferred, though itshould be understood that the thickness may vary according to thematerial used as will be well understood in the art.

As best shown in FIG. 2, the first step in the construction of thefastener 10 is to produce a generally flat annular pattern (generallyreferred to by the reference number 10) from a sheet of material,wherein the pattern has the first and second sets of fingers 24, 26extending radially inwardly toward one another. Desirably, the patternhas diametrically opposite loops 21 extending radially outwardly fromthe annulus 18. The loops 21 act at least in part as spring joints tofacilitate returning the apparatus 10 to its unbiased form upondeployment of the fastener 10 as will be described hereafter. The methodof manufacture of the fastener 10 may incorporate a variety ofconstruction methods, for example and without limitation, photo-chemicaletching, laser cutting, die punching, electric discharge machining(EDM), and other methods of construction, as desired and as wellunderstood by those skilled in the art. It should be understood that thefirst and second sets of fingers 24, 26 may be constructed havingdifferent lengths from one another.

To facilitate bonding between tissue and the fastener 10 as part of thehealing process after the fastener 10 is placed, both sides of the flatannual pattern, particularly the inner surfaces 32, 38 and the outersurfaces 34, 40 are preferably provided with a surface texture orroughed generally having a surface finish of about 30-60 RMS using aprocess such as chemical etching, or mead-blasting, for example. Bycreating a roughed surface, the tissue is better able to bond to thefastener 10. Alternately, the fastener 10 may be coated either at thefirst stage of construction or later with a material to facilitate orstrengthen tissue growth or minimize infections or a combination ofthese.

As shown in FIG. 4, desirably, while the fastener 10 is in its initiallyconstructed flat configuration, the bevels 36 are formed on the firstset of fingers 24. While forming the bevels 36 on the first set offingers 24, the flat annual pattern is placed between a pair ofgenerally flat dies or plates 44, 46. Each plate 44, 46 has a throughhole 48, 50, respectively, sized to allow the first set of fingers 24 toextend radially inwardly into the through holes 48, 50 uponconcentrically aligning the through holes 48, 50 and the first set offingers 24 with one another along the axis 20. The plate 44 has acounter bore 52 to allow the first set of fingers 24 to deflect duringthe formation of the bevels 36.

In forming the bevels 36 on the first set of fingers 24, the fastener 10is maintained between the plates 44, 46 so that a sharpening tool, forexample and without limitation, a honing rod 54, can be passed in onedirection, represented by arrow A, through the through holes 48, 50 ofthe plates 44, 46 to engage the free ends 28 of the first set of fingers24. Accordingly, as the honing rod 54 engages the first set of fingers24, the fingers deflect generally in the direction of arrow A, into thecounter bore 52. As such, material is removed from the first set offingers 24 to form the bevels 36. It should be recognized that thehoning rod 54, in addition to being passed axially through the throughholes 48, 50 of the plates 44, 46, can be rotated about the axis 20 inthe direction of arrows B to facilitate forming a uniform bevel 36 oneach of the first set of fingers 24.

As shown in FIG. 5, desirably, while the fastener 10 is in its initiallyconstructed flat configuration, the bevels 42 are formed on the secondset of fingers 26. While forming the bevels 42 on the second set offingers 26, the flat annual pattern is placed between a pair ofgenerally flat dies or plates 56, 58. Each plate 56, 58 has an outerdiameter 60, 62, respectively, sized to allow the second set of fingers26 to extend radially outwardly therefrom upon concentrically aligningthe outer diameters 60, 62 and the second set of fingers 26 with oneanother along the axis 20, with the fastener 10 maintained between theplates 56, 58. The plate 56 has a recessed surface 64 to allow thesecond set of fingers 26 to deflect during the formation of the bevels42.

In forming the bevels 42 on the second set of fingers 26, the fastener10 is maintained between the plates 56, 58 so that a sharpening tool,for example and without limitation, a honing cylinder 66, can be passedin one direction, represented by arrows C, generally in the samedirection as arrow A in which the honing rod 54 is passed, to engage thefree ends 30 of the second set of fingers 26. The honing cylinder 66 hasa bore 68 greater in diameter than the outer diameters 60, 62 of theplates 56, 58 and less than the outer diameter of the second set offingers 26. Accordingly, as the honing cylinder 66 passes over thesecond set of fingers 26, the bore 68 engages the free ends 30 of thesecond set of fingers 26 to deflect the fingers 26 generally in thedirection of arrow C, toward the recessed surface 64. As such, materialis removed from the second set of fingers 26 and the bevels 42 areformed.

The flat annular pattern, as shown in FIG. 2, is then elasticallydeformed to provide the finished, unbiased shaped of the fastener 10, asbest shown in FIGS. 1 and 3 by preferably bending or deforming alternatefingers upwardly and downwardly, respectively, to form the first andsecond sets of fingers 24, 26, and to form the radially outwardlyextending flange 19. The deformed pattern is maintained in the desiredfinish shape by subjecting the elastically deformed pattern to acontrolled heat treatment process. During the heat treatment process,the deformed pattern is raised to the critical temperature of thematerial, for example, about 932.degree. F. for nitinol, between about800-1200.degree. F. for MP35N, and is then quenched, preferably inwater, to retain the pattern in conformity with the outer surfaces ofthe dies. Upon finishing the heat treatment process, the first set offingers 24 are shaped to their unbiased, generally arcuate configurationextending at least partially generally radially outwardly from theperpendicular axis 20, while the second set of fingers 26 are shaped totheir unbiased, generally arcuate configuration extending at leastpartially generally radially outwardly from the perpendicular axis 20.

Alternatively, as shown in FIGS. 6-8, the fastener 10 may be fabricatedfrom separate pieces of selected material, such as from theaforementioned materials, wherein the annulus 18 is fabricatedseparately from the fingers 24, 26. A plurality of through openings 70are formed about the circumference of the annulus 18 at predeterminedand preferably equally spaced locations from one another. Throughopenings 70 may be formed by any means well known in the art including,but not limited to, micro-drilling, etching or laser-drilling.

The annulus 18 is then preferably heat formed to its intended finishshape (FIG. 7), whereupon the one piece fingers 24, 26 are inserted intothe through openings 70 a predetermined distance, and preferably totheir midpoint. The fingers 24, 26 are preferably fixed in the openingsby way of a weld joint such as is well understood by those skilled inthe art.

Upon forming the fastener 10 to its finished configuration, the fastener10 is preferably subjected to a passivating process to remove anyimpurities from the surfaces of the fastener 10. The passivation may beachieved by electropolishing, chemical passivation, or a hybridtechnique known as selective abstraction passivation. Theelectropolishing passivation process utilizes a reducing acidenvironment in conjunction with a source of DC power. Theelectropolishing process removes impurities from the surfaces of thefastener 10 to a depth of about 20-30 angstroms, depending on theexposure time of the fastener 10 to the reducing acid environment and DCpower. The chemical passivation process can be performed in a variety ofmanners, for example, pickling, wherein the fastener 10 is immersed in asolution of hydrofluoric acid (HF) and nitric acid (HNO3) for a periodof time; chelant passivation (citric acid), and selective abstraction,wherein a specifically formulated abstraction chemistry is used inconjunction with electrolysis. The selective abstraction techniqueremoves only the readily soluble passive film contaminants such as iron,nickel, aluminum (grinding residue), and the like. Upon passivating thesurfaces of the fastener material, desirably the fastener 10 is cleanedutilizing a plasma cleaning process.

The plasma cleaning process removes all foreign materials remaining onthe surfaces of the fastener material. Some of the plasma cleaningmechanisms that may be used includes, for example, induction coupledbarrel reactors and capacitance coupled parallel plate reactors.

Upon cleaning the surfaces of the fastener 10, preferably the surfacesare at least partially coated with a bio-adhesive material to facilitateforming a cohesive bond between the fastener 10, the tubular duct 12 andthe vessel 16. The bio-adhesive materials may include by-products of thepatient's own blood, for example, platelet gel formed from the patient'sblood. Otherwise, biocompatible adhesives including calcium, for exampleand without limitation, may be used. These same bio-adhesives may alsobe introduced while attaching the fastener 10 to the tubular duct 12 andthe vessel 16, as discussed in more detail hereafter. As shown generallyin FIGS. 10A-10G, upon coating the fastener 10 with the bio-adhesive,the fastener 10 is generally ready for deployment by an apparatus,referred to hereafter as a deployment tool 72.

As shown in FIG. 10, the deployment tool 72 has a main body 74 with aluminary guide, hereafter referred to as a guide member 76, received onthe main body 74 for slidable relative movement therealong between aretracted loading position (FIG. 10A) and an extended deploying position(FIG. 10G). As shown in FIGS. 11-13, to facilitate the slidable movementof the guide member 76, the body 74 preferably has a lateral slot 78within one and preferably opposite sidewalls 80 of the body 74 forreceipt of guide fingers 82 depending from the guide member 76. The body74 has upper and lower walls 84, 86 with inclined surfaces 88 preferablyhaving concave surfaces converging toward each other adjacent an end 90of the body 74. A longitudinal channel 92 extends through the upper andlower walls 84, 86 from the end 90 of the body 74 toward a handle 94 ofthe body 74. The channel 92 has sidewalls that define a fastener cavity96 sized to receive and maintain the fastener 10 in its biased andgenerally flattened position between the sidewalls by engaging thefingers 24, 26 of the fastener 10 until a user is ready to deploy thefastener 10 into the selected tissues, as shown in part in FIG. 12. Itshould be understood that though FIG. 12 shows the fingers 24, 26 stillin their biased position for demonstration of the slidable movement ofthe fastener apparatus 10, they actually would take on their nonbiasedcurved configuration in use. A pair of recesses 98 (FIGS. 21-24) extendlaterally outwardly from the channel 92, wherein the recesses 98 aresized to receive the annulus 18 of the fastener 10 to facilitate guidedslidable movement of the fastener 10 through the channel 92. The channel92 is also sized to allow a portion of the guide member 76 to slidetherethrough as the main body 74 of the deployment apparatus 72 is movedaxially relative to the guide member 76.

As shown in FIG. 12, the guide member 76 has an axially extendingreceptacle 100 sized to receive the tubular duct 12 thereon. Thereceptacle 100 has a pair of bodies 101, 102 spaced laterally from oneanother to define a cutter channel 104. Each body 101, 102 preferablyhas upwardly extending flanges 106 with cutter slots 108 extendingaxially along each flange 106. The slots 108 carry a cutter 110 via tabs112 extending laterally outwardly from the cutter 110 for slidablemovement within the slots 108. Preferably, each body 101, 102 has alower concave surface 114 flaring from a bottom of the bodies 101, 102laterally outwardly from one another to provide partially guided supportfor the fastener apparatus 10 as it is being deployed.

The function of cutter 110, as will be explained in detail hereafter, isto cut tissue. Specifically, the function of cutter 110 is to cut thetissue of the wall 11 of the tubular duct 12 and the wall 14 of a vessel16 after the fastener 10 is deployed in the tissue of the tubular duct12 and vessel 16 as shown in FIG. 25. Consequently, cutter 110 must havea sharp edge that may cut the tissue of the tubular duct 12 and vessel16. In one embodiment of the fastener 10, the cutter 110 may take theform of a small surgical blade. In another embodiment of the fastener 10the cutter 110 may take the form of a sharpened surgical wire. Otherforms for cutter 110 will occur to those skilled in the art that meetthe functional requirements of cutter 110 as explained herein.

The guide member 76 has a housing 116 sized for reciprocating movementof an actuator rod 118. The rod 118 has one end 119 preferably having anotch 120 arranged for attachment to the cutter 110 via a pin 122 toprovide pivotal movement of the cutter 110 relative to the rod 118, andanother end arranged for operable attachment to an actuator triggermechanism. Accordingly, when the trigger mechanism is actuated, such asby being moved from a first retracted position to a second depressedposition, the actuator rod 118 slides within the housing 116 toward thetrigger, thereby causing the blade 110 to pivot to a cutting position.In addition, to the pivotal movement of the cutter 110, the cutter 110is caused to slide within the cutter channel 104 from a free end of thereceptacle 100 toward the handle or trigger during a cutting procedureby pulling on the trigger. As such, the cutter 110 moves from anextended initial position to a retracted final position upon making anincision.

In deployment, as shown in FIG. 14, the surgeon can facilitate locatingthe fastener apparatus by tagging a point (P) of attachment on thevessel 16 with a suture 124. As shown in FIG. 15, at least one of theends and shown here as both ends of the suture 124 are fed through atleast one of the loops 21 in the fastener apparatus 10 and through theaxial channel 92 in the main body 74 of the deployment apparatus 72. Thesuture ends are then preferably stitched through the tubular graft 12adjacent its end.

As shown in FIG. 16, the graft 12 is then disposed on the receptacle 100with the suture 124 being received in part between an end of the graft12 and the deployment apparatus 72. As shown in FIGS. 17 and 21, thedeployment apparatus 72, with graft thereon, is positioned on the vessel16, as facilitated by the guided assistance provided by the taggedsuture 124. Thereafter, the fastener apparatus 10 is deployed bypreferably pulling the main body 74 to move the guide member 76 to itsextended deployed position, as shown in FIGS. 18 and 22-25. It should beunderstood that though FIG. 18 shows the fingers 24, 26 still in theirbiased position for demonstration of the slidable movement of thefastener apparatus 10, they generally would take on their nonbiasedcurved configuration in use to attach themselves to the graft 12 and theunderlying tissue vessel 16.

In FIGS. 22-25, the fingers 24, 26 of the fastener apparatus 10 areshown in progressive states of movement as they take on their unbiasedform and are deployed into the tissues being joined. The fingers 24, 26begin to take their unbiased shape upon clearing the confines of themain body 74 of the deployment apparatus 72 as the main body 74 ispulled, and as the receptacle 100 and the graft 12 are slid downwardlyalong the upper wall 84 of the main body 74 (FIG. 22). At the same time,the underlying tissue vessel 16 slides along the lower wall 86, thusallowing the lower fingers 26 to penetrate the underlying tissue vessel16 at the same time and rate as the upper fingers 24 penetrate the graft12. In FIG. 23, the fingers 24, 26 are shown in a partially curled statewhere they begin to turn back generally toward one another, therebypreferably imparting a bias to pull the graft 12 and the underlyingtissue vessel 16 toward one another.

As shown in FIGS. 19 and 26, the cutter 110 is then pivoted to itscutting position about the pin 122 by depressing the lever or trigger,thereby moving a cutting tip of the cutter 110 into a cutting position.The cutter 110 is then actuated by pulling the actuator rod 118, therebycausing the cutter 110 to traverse along the receptacle 76 via guidedmovement facilitated by the cutter slots 108 in the flanges 106 to forman incision through the graft 12 and the underlying tissue vessel 16,with the cutter 110 extending between the opposite sides of the annulus18 and through the cutter channel 92 in the main body 74. Uponcompletion of the incision, as shown in FIGS. 27 and 28, the fastenerapparatus 10 is generally free to assume its unbiased state, therebyestablishing an opening 126 between the joined graft 12 and underlyingtissue vessel 16 to provide blood flow through the opening 126. As shownin FIG. 20, the end of the graft 12 is then closed off, such as by apurse string suture 126, for example.

In FIG. 29, another fastener apparatus 210 constructed according toanother preferred embodiment of the invention is shown making agenerally tangential anastomosis between a generally tubular duct 12 anda wall 14 of a vessel 16. The fastener apparatus 210 has an annulus 218constructed generally the same as the annulus 18 in the firstembodiment, with a first set of fingers 224 extending axially in onedirection from the annulus 218. The fingers 224 are constructedgenerally the same as the first or second sets of fingers 24, 26 in thefirst embodiment, and thus are not described in further detail. As shownin FIG. 30, the fastener apparatus 210 has a generally similar preformedconfiguration as the fastener apparatus 10 in the previous embodiment,however all of the fingers 224 are formed in the same axial direction,rather than alternating axial directions as in the previous embodiment.The apparatus 210 is shown in FIG. 30 having eyelets 211 extendinglaterally from a pair of loops 221 to facilitate threading a taggingsuture 124, otherwise, the construction of the fastener apparatus 210 isthe same, and is not discussed further.

In deployment, as shown generally in FIG. 31, a deployment apparatus 272has a receptacle 273 sized for receipt within a selected tubular duct orgraft 12. With the fastener apparatus 210 disposed in the receptacle 273(FIG. 32), the fingers 224 are biased toward a flattened state (FIG.31), as in the previous embodiment. Upon inserting the tubular duct 12over the receptacle 273, and positioning the tubular duct 12 in theintended location of attachment relative to the tissue vessel 16, thefastener apparatus 210 is deployed generally similarly as in theprevious embodiment, however, the annulus 218 is received internally tothe graft 12, while the fingers 224 penetrate through a wall 215 of thegraft 12 and into the adjoining tissue vessel 16. As such, the annulus218 itself acts to partially bias the graft 12 into abutting contactwith the underlying tissue vessel 16 by engaging an internal surface 217of the graft wall 215. It should be recognized that the tagging suture124 may also be used to facilitate attachment of the fastener apparatus210, as in the previous embodiment. Because the annulus 218 itself actsto partially bias the graft 12 into abutting contact with the underlyingtissue vessel 16, it may be desirable to may annulus 218 wider thanannulus 18 so that there is more surface area on annulus 218 in contactwith the tissue vessel 16. In this way, there is less of a chance thatthe annulus 218 will cut into the tissue of the tissue vessel 16.

As shown in FIG. 33, another embodiment of a fastener apparatus 310 hasa discontinuous annulus 318. One end 312 of the annulus 318 has agenerally hook shaped end, while another end 314 has a generally loopedend sized for receipt of the hooked end 312. Otherwise, one or two setsof fingers (not shown) may extend axially from the annulus 318, as inthe previous embodiments.

As shown in FIG. 34, another embodiment of a fastener apparatus 410generally similar to the previous embodiment is shown, however, theapparatus 410 has a continuous loop of material forming an annulus 418.Opposite ends 412, 414 of the annulus 418 are preferably twisted to formloops 416 to facilitate guided attachment of the apparatus 410 by atagging suture 124, as described above.

As shown in FIGS. 35 and 36, another presently preferred embodiment of afastener apparatus 510 has an annulus 518 constructed from a pair ofresilient springy wires 512, 514. Each wire 512, 514 has ends with oneof a loop formation 516 and a hook formation 517, wherein the loops andhooks are arranged for attachment to an adjoining hook or loop on theopposite wire. It should be recognized that the annulus 518 may have oneor two sets of fingers 24, 26, as described above, depending on thenature of the tissue connection.

As shown in FIG. 37, another presently preferred embodiment of theinvention has an annulus 618 similar to the previous embodiment withfirst and second sets of fingers 624, 626 constructed from coiled springwire. The first and second fingers 624, 626 are laterally spaced fromone another by a coiled section 612 that defines a through opening 614preferably sized for a tight fit about the annulus 618. The coiledsection 612 may be defined by a plurality of coils to space the fingers624, 626 laterally from one another, or the coil can be formed by asingle coil, thereby locating the first and second fingers 624, 626adjacent one another. As such, the number of first and second fingers624, 626 may be altered or tailored for the specific type of anastomosisbeing formed. It should be recognized that the gage or diameter ofspring wire may be altered, as desired. Otherwise, it should berecognized that the first and second fingers 624, 626 can be generallyconstructed the same as described above.

It is to be understood that the embodiments discussed above areexemplary embodiments of the presently preferred constructions, and thusare intended to be illustrative and not limiting. The scope of theinvention is defined by the following claims.

1. An apparatus for securing a tubular duct having a wall to a vesselhaving a wall in a side by side configuration, comprising: acircumferentially continuous annulus having a first set of fingersextending from the annulus in a first direction, the first set offingers being configured for automatic movement from a first biasedconfiguration toward a heat-formed, relaxed second configuration; andthe first set of fingers being configured to penetrate and grasp thewall of either the tubular duct or vessel as they move from the firstconfiguration toward the second configuration.
 2. The apparatus of claim1 wherein the first set of fingers are formed as a monolithic piece ofmaterial with the annulus.
 3. The apparatus of claim 1 wherein the firstset of fingers is configured to penetrate the wall of the tubular ductas they move from the first configuration toward the secondconfiguration; and further comprising a second set of fingers extendingat least in part from the annulus in a second direction generallyopposite the first direction, the second set of fingers being configuredfor automatic movement from a first biased configuration toward aheat-formed second relaxed configuration; and the second set of fingersbeing configured to penetrate and grasp the wall of the vessel as theymove from the first configuration toward the second configuration. 4.The apparatus of claim 3 wherein each finger of the first and secondsets of fingers has a generally arcuate shape in the secondconfiguration.
 5. The apparatus of claim 4 wherein each finger of thefirst and second sets of fingers has a substantially flat shape in thefirst configuration.
 6. The apparatus of claim 5 wherein each finger ofthe first and second sets of fingers are substantially coplanar with oneanother in the first configuration.
 7. The apparatus of claim 3 whereinthe second set of fingers are formed as a monolithic piece of materialwith the annulus.
 8. The apparatus of claim 1 wherein each finger of thesecond set of fingers has a generally arcuate shape in the secondconfiguration.
 9. The apparatus of claim 1 wherein each finger of thefirst set of fingers has a generally arcuate shape in the secondconfiguration.
 10. The apparatus of claim 3 wherein the first set offingers are circumferentially staggered relative to the second set offingers.
 11. The apparatus of claim 1 wherein the circumferentiallycontinuous annulus is formed in a plane having a longitudinal axisextending along the plane and a perpendicular axis extendingperpendicular to the plane, wherein the annulus has a bias impartedtherein to provide the annulus with a biased first configuration and anunbiased second configuration; wherein the biased first configurationhas opposite sides of the annulus across the longitudinal axis in closeproximity to each other along the longitudinal axis to form anelongated, substantially closed slit and, wherein the unbiased secondconfiguration has opposite sides of the annulus across the longitudinalaxis spaced apart from each other; and wherein the annulus isautomatically biased to move from the biased first configuration towardthe unbiased second configuration.
 12. A method for deploying a fastenerto secure a tubular duct having a wall to a vessel having a wall in aside by side configuration, comprising: constraining a first set offingers of the fastener with a deployment apparatus to move the firstset of fingers into a biased state; disposing the constrained fastenerbetween the tubular duct and vessel; and releasing the constrainedfastener from the deployment tool to allow the first set of fingers toassume a relaxed, unbiased shape and penetrate and grasp at least one ofthe tubular duct and vessel so that the fastener grasps and fixes thetubular duct and vessel to each other.
 13. The method of claim 12further including forming an opening within at least one of the tubularduct and vessel to allow blood to flow through the opening by extendinga cutting member on the deployment tool between the first set of fingersand cutting tissue of at least one of the tubular duct and vessel withthe cutting member.
 14. The method of claim 12 further includingconstraining a second set of fingers of the fastener with the deploymentapparatus to move the second set of fingers into a biased state andallowing the second set of fingers to assume a relaxed, unbiased shapeand penetrate and grasp at least one of the tubular duct and vessel uponreleasing the constrained fastener from the deployment tool.
 15. Themethod of claim 14 further including biasing the first and second setsof fingers into a substantially coplanar relation with one another whileconstraining the first and second sets of fingers.
 16. The method ofclaim 15 further including allowing the first and second sets of fingersto take on an arcuate heat-shaped configuration upon releasing theconstrained fastener from the deployment tool.